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Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy (QoR-SCPB)

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bupivacaine
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Superficial Cervical Plexus Block, Quality of Recovery, Postoperative Pain, Thyroidectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 years or older American Society of Anesthesiologists Physical Status classification I-III Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Scheduled for thyroid surgery Access to smartphone device or computer with internet connection and has an email address Exclusion Criteria: Non-English speaking American Society of Anesthesiologists Physical Status classification > III Have an intolerance or contraindication to the medications involved in the study Undergoing repeat thyroid surgery Undergoing surgery with planned neck dissection Plan for admission post-operatively Positive pregnancy test on day of surgery (for participants with child-bearing potential) Refusal to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Bupivacaine

    Placebo

    Arm Description

    Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.

    Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.

    Outcomes

    Primary Outcome Measures

    Quality of Recovery-40 (QoR-40) questionnaire score on postoperative day (POD) 1
    The QoR-40 is a widely used and well validated metric assessing postoperative quality of recovery. It includes 5 subsections investigating the dimensions of 'Emotional State' (9 questions), 'Physical Comfort' (12 questions), 'Psychological Support) (7 questions), 'Physical Independence' (5 questions), and 'Pain' (7 questions) for a total of 40 questions. The questions are scored on a 5-point Likert scale. Possible responses range from 1 = 'none of the time' to 5 = 'all of the time'. For negative items, the Likert scale is reversed. The individual scores are summed for the total score which can range from 40 points to 200 points. A higher score indicates better post-operative quality of recovery. Participants will be sent an electronic link to the survey via their email. They will complete the surveys privately from their own electronic devices. Investigators will then compare the changes in pre-operative vs POD 1 QoR-40 scores between the two groups.

    Secondary Outcome Measures

    Opioid consumption postoperatively
    This outcome will be measured in morphine milligram equivalents. The data will be obtained from electronic medical record (EMR) review. It will be measured from the start of the participant's post-anesthesia care unit (PACU) stay and through POD 1.
    Need for rescue analgesia prior to PACU discharge
    This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review from the start of participant's PACU stay to end of participant's PACU stay
    Presence of nausea and/or vomiting in the PACU
    This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
    Need for rescue antiemetics in PACU
    This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
    PACU length of stay
    This outcome will be measured in minutes. The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
    Presence of patient reported side effects
    Participants will self-report any side effects that they experienced post-operatively from the start of their PACU stay and through POD 1.
    Patient reported quantity of other modes of analgesia, if any through POD 1
    Participants will self-report any other modes of analgesia used post-operatively from the start of PACU stay and through POD 1.

    Full Information

    First Posted
    August 14, 2023
    Last Updated
    August 21, 2023
    Sponsor
    Yale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06002152
    Brief Title
    Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy
    Acronym
    QoR-SCPB
    Official Title
    Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 18, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn whether a superficial cervical plexus block improves quality of recovery after thyroid surgery. Investigators will compare a superficial cervical plexus block with bupivacaine compared to an identical procedure performed saline placebo to see if there is a difference in quality of recovery on the first postoperative day. The main question to answer is: • Does a superficial cervical plexus block with bupivacaine compared to placebo improve quality of recovery in patients having thyroid surgery. Participants will: Fill out an initial preoperative survey Be randomized to receive a superficial cervical plexus block with bupivacaine or saline placebo while under anesthesia before the surgery starts Fill out a survey about recovery on the first day after surgery
    Detailed Description
    Thyroid surgery is associated with mild to moderate post-operative pain, with most patients requiring opioid pain medicine postoperatively. Nerve blocks, such as the superficial cervical plexus block, are an important component of pain control plans. Superficial cervical plexus blocks have been proven to decrease pain and reduce the need for opioid medications in thyroid surgery. However, previous studies were performed before it became common practice to administer a combination of acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and steroids for thyroid surgery which also help with pain. Whether the superficial cervical plexus block improves pain control and quality of recovery in this context is unknown. This study aims to determine whether the superficial cervical plexus block has an impact on quality of recovery as measured by a survey called the Quality of Recovery-40 (QoR-40).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Superficial Cervical Plexus Block, Quality of Recovery, Postoperative Pain, Thyroidectomy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bupivacaine
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Description
    After anesthesia induction and prior to the start of surgery, the superficial cervical plexus block will be performed according to standard protocol by an experienced blinded clinician. In this arm, participants will receive 10 milliliters of 0.25% bupivacaine on both sides of their neck for this block. This will be the only intervention administered for purposes of this study.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    After anesthesia induction and prior to the start of surgery, the superficial cervical plexus block will be performed according to standard protocol by an experienced blinded clinician. In this arm, participants will receive 10 milliliters of saline on both sides of their neck for this block. This will be the only intervention administered for purposes of this study.
    Primary Outcome Measure Information:
    Title
    Quality of Recovery-40 (QoR-40) questionnaire score on postoperative day (POD) 1
    Description
    The QoR-40 is a widely used and well validated metric assessing postoperative quality of recovery. It includes 5 subsections investigating the dimensions of 'Emotional State' (9 questions), 'Physical Comfort' (12 questions), 'Psychological Support) (7 questions), 'Physical Independence' (5 questions), and 'Pain' (7 questions) for a total of 40 questions. The questions are scored on a 5-point Likert scale. Possible responses range from 1 = 'none of the time' to 5 = 'all of the time'. For negative items, the Likert scale is reversed. The individual scores are summed for the total score which can range from 40 points to 200 points. A higher score indicates better post-operative quality of recovery. Participants will be sent an electronic link to the survey via their email. They will complete the surveys privately from their own electronic devices. Investigators will then compare the changes in pre-operative vs POD 1 QoR-40 scores between the two groups.
    Time Frame
    Up to 2 days
    Secondary Outcome Measure Information:
    Title
    Opioid consumption postoperatively
    Description
    This outcome will be measured in morphine milligram equivalents. The data will be obtained from electronic medical record (EMR) review. It will be measured from the start of the participant's post-anesthesia care unit (PACU) stay and through POD 1.
    Time Frame
    Up to 2 days
    Title
    Need for rescue analgesia prior to PACU discharge
    Description
    This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review from the start of participant's PACU stay to end of participant's PACU stay
    Time Frame
    approximately 4 hours
    Title
    Presence of nausea and/or vomiting in the PACU
    Description
    This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
    Time Frame
    approximately 4 hours
    Title
    Need for rescue antiemetics in PACU
    Description
    This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
    Time Frame
    approximately 4 hours
    Title
    PACU length of stay
    Description
    This outcome will be measured in minutes. The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
    Time Frame
    approximately 4 hours
    Title
    Presence of patient reported side effects
    Description
    Participants will self-report any side effects that they experienced post-operatively from the start of their PACU stay and through POD 1.
    Time Frame
    up to 2 days
    Title
    Patient reported quantity of other modes of analgesia, if any through POD 1
    Description
    Participants will self-report any other modes of analgesia used post-operatively from the start of PACU stay and through POD 1.
    Time Frame
    up to 2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 years or older American Society of Anesthesiologists Physical Status classification I-III Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Scheduled for thyroid surgery Access to smartphone device or computer with internet connection and has an email address Exclusion Criteria: Non-English speaking American Society of Anesthesiologists Physical Status classification > III Have an intolerance or contraindication to the medications involved in the study Undergoing repeat thyroid surgery Undergoing surgery with planned neck dissection Plan for admission post-operatively Positive pregnancy test on day of surgery (for participants with child-bearing potential) Refusal to participate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jaime Hyman, MD
    Phone
    203-785-2802
    Email
    jaime.hyman@yale.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anita M Jegarl, BS
    Phone
    203-785-2802
    Email
    anita.jegarl@yale.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy

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